Programme

Registration

Chairman’s Introduction

Speaker:
David Kill

The Regulatory Requirement - Why SOPs?

• The philosophy underpinning SOPs and the practical need for SOPs.
• Regulatory Requirements: what they are and what they require - what must be covered
• Regulatory Inspection – who inspects, what they inspect and what causes the most problems most often.
• What regulators expect to find. How they react when their expectations are not met.
• Understanding the philosophy of regulation and the regulatory environment
• Changes expected due to EU Directives
• How to ensure that SOPs can evolve to meet regulatory updates without excess pain.

Speaker:
Susan Ollier

The place of SOPs in ‘The Quality System’

• Understanding what are: 
• The Quality System
• Quality Processes
• Where SOPs fit in
• Which SOPs are needed and why
• Inspection findings and SOPs

Speaker:
Steve Nicholas

SOP writing, reviewing and lifecycle management

• How to write and review SOPs – in detail
• Life cycle management and SOPs
• Examples of how not to do it and the consequences of getting it wrong

Speaker:
David Kill

Refreshments

The essentials of ‘Process Mapping’

• What a process map is and what a good process map delivers
• Why they are used, who uses them and how they are used
• Mapping a simple process, incorporating details to optimise utility and use

Speaker:
Steve Nicholas

Making SOPs part of a process-centric model

• Why the process view is critical
• Process and SOP integration
• Managing a compliant process model
• Validation technical challenges

Speakers:
Tania Carter
Gary Chitan

Lunch

Case Study: Work Flow based SOPs – what has been achieved and what can be achieved

• An example for format
• People were the glue
• Re-Engineering is best
• Top down or Bottom up?
• Get the right people
• Work flows are fast
• Consider the user
• Ownership
• Knowing when to stop

Speaker:
Gareth Turner

Case Study: A SOP process map project that improved both operational performance and clinical compliance

The motivation

Realization that process-based SOPs can greatly improve understanding of what must be done and how to do to achieve optimal compliance and operational efficiency led a major global pharmaceutical company to map its clinical processes.

The project

Proprietary software was used for both process-map creation and storage. Software enabled maps to be ‘tagged’ with important information including input/output data, ownership/organization details and computer applications used by the process.

Achievement

Over a two year period processes were mapped and a holistic picture of the company’s clinical processes created that delivered both the means of supplying essential compliance information to clinical staff and an enhanced analytical capability to support process and organizational improvement.

Speaker:
Richard Winning

Refreshments

What works and what does not in SOP training

• Understanding what ‘SOP training’ encompasses
• Who is responsible for what – creating motivation
• Timing the training for maximum effect
• Effective learning methods
• Establishing how well the training has worked
• When training isn’t the answer
• Creating a SOP on training

Speaker:
Martin Robinson

Software showcase: Making the vision a reality – A working example of eSOPs/QMS

• What does a personalized SOP content management solution look like
• How does content governance work
• Training and R&U in action

Speaker:
Gary Chitan

SOP Surgery: Good Practices that Greatly Increase Productivity and Reduce the Risk of Failure

• Constructing SOP document hierarchies and networks
• Optimising the amount of detail in the SOP:  text v workflow
• Overcoming organisational inertia
• Achieving user buy-in

Conference attendees are invited to submit in advance the SOP problems that they wish to have addressed. Complete confidentiality, including information on who has submitted the question, will be maintained. Please contact Patricia Connelly on patriciac@henrystewart.co.uk to submit a question.

Chairman’s Summary and Close of Proceedings